Phase I study of the ¹⁷⁷Lu-DOTA⁰-Tyr³-Octreotate (lutathera) in combination with nivolumab in patients with neuroendocrine tumors of the lung.

ABSTRACT:

Background

Lutathera is a ¹⁷⁷Lutetium-labeled somatostatin analog approved for the treatment of gastroenteropancreatic neuroendocrine tumors (NETs). Somatostatin receptors are expressed in small cell lung cancer (SCLC). Nivolumab, an anti-PD-1 antibody, may act synergistically with lutathera to generate antitumor immunity. We conducted a phase I study of lutathera plus nivolumab in patients with advanced NETs of the lung.

Methods

Patients with relapsed/refractory extensive-stage SCLC (ES-SCLC), non-progressing ES-SCLC after first-line platinum-based chemotherapy, or advanced grade I-II pulmonary NETs were eligible. The primary objective was to determine the recommended phase 2 dose (RP2D). The phase I portion followed a standard 3+3 design, assessing two dose leve

SUBMITTER: Kim C 

PROVIDER: S-EPMC7333915 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature